Release Date: November 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- BioArctic AB (BRCTF, Financial) reported a significant increase in royalties from Leqembi sales, with over 60% growth compared to the previous quarter.
- The company's BrainTransporter technology is progressing well, with promising preclinical data showing enhanced brain distribution in both transgenic mice and nonhuman primates.
- BioArctic AB (BRCTF) maintains a solid financial position, with SEK 804 million in cash and short-term investments, allowing continued focus on project development.
- The company's pipeline is advancing, with the initiation of Phase 2A studies for Parkinson's disease and plans to start dosing soon.
- Leqembi has been approved and launched in multiple countries, including the US, Japan, and China, with sales exceeding expectations in Japan and China.
Negative Points
- BioArctic AB (BRCTF) experienced a decrease in net revenues compared to the previous year, primarily due to the absence of milestone payments.
- The company faces challenges with infusion capacity for Leqembi in the US, which has limited sales growth despite high demand.
- Operating expenses have increased, particularly in R&D, which is expected to continue rising as project development progresses.
- There is uncertainty regarding the approval of Leqembi in the EU, with the outcome of the CHMP opinion still pending.
- BioArctic AB (BRCTF) has not yet achieved profitability, although growing royalties are starting to offset R&D expenses.
Q & A Highlights
Q: Could you elaborate on the BrainTransporter technology results and its potential impact on brain exposure for antibodies?
A: Per-Ola Freskgård, VP Science & Technology, explained that their BrainTransporter technology uses a novel binding site on the transferrin receptor, which may lead to improved brain exposure and safety profiles compared to competitors. The technology is expected to deliver similar or better results with other antibodies.
Q: What kind of data updates can we expect on the BrainTransporter technology at the upcoming AGPD conference?
A: Per-Ola Freskgård mentioned that they plan to share additional data on their most advanced program using the BrainTransporter technology, focusing on CMC and development timelines.
Q: How do you foresee the role of blood-based biomarkers in the adoption of Leqembi?
A: CEO Gunilla Osswald stated that blood-based biomarkers are currently used for screening, but they expect them to be used for confirmation soon, potentially starting next year. This development will simplify the patient journey and aid in easier diagnosis.
Q: If the CHMP opinion on Leqembi is positive, what are the expected timelines for launching in the Nordic region under the co-promotion agreement?
A: CFO Anders Martin-Löf indicated that market access processes are led by Eisai, and while timelines are estimates, they hope to launch in early 2026 if approval is granted.
Q: What is the expected timeline for BioArctic's Alzheimer's project using BrainTransporter technology?
A: CEO Gunilla Osswald mentioned that their most advanced BrainTransporter program in Alzheimer's Disease is expected to enter the clinical setting by 2026.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
